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Apidra approved for pediatric diabetes

The FDA has approved Apidra (insulin glulisine [rDNA origin] injection, from sanofi-aventis) for the treatment of type 1 diabetes in children ≥4 years old. This approval was based on a 26-week, open-label trial comparing Apidra to insulin lispro in 572 children and adolescents with type 1 diabetes that showed efficacy and side effects were similar in both groups based on HbA1c, self-monitored glucose values, and reports of hypoglycemia.